The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Iris - High Strength Glass Ceramic.
| Device ID | K123615 |
| 510k Number | K123615 |
| Device Name: | IRIS - HIGH STRENGTH GLASS CERAMIC |
| Classification | Powder, Porcelain |
| Applicant | DENTSPLY INTL. 21 W PHILADEPHIA STREET SUITE 60W York, PA 17405 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTL. 21 W PHILADEPHIA STREET SUITE 60W York, PA 17405 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-23 |
| Decision Date | 2013-02-22 |
| Summary: | summary |